Regulatory Affairs Analyst
About Scopio Labs
Scopio Labs is a fast-growing medical technology company transforming the fields of hematology and cell morphology analysis. As a team, we work to enable faster, earlier detection and diagnosis of blood-related diseases, so patients can start treatment sooner and have better outcomes. We are collaborative and global – and every individual at Scopio Labs is part of a life-saving mission.
About the job
We are looking for a Compliance & Regulatory Affairs Analyst to join our Compliance and RA team. Scopio’s Compliance and RA team is responsible for the company’s regulatory activities, quality management system, and for ensuring compliance with applicable standards, including standards related to security and privacy.
The team plays a central role in both pre-market and post market activities. The Compliance & RA analyst will take an important role in the company’s regulatory, quality and compliance activities, including – supporting the Company's global regulatory activities, ensuring compliance with the relevant quality standards (including ISO 13485:2016 and 21 CFR 820), Supporting internal audits and Post Market activities.
What you will be doing:
- Support the company’s regulatory activities – analyzing regulatory requirements in different territories, continually monitoring the regulatory environment.
- Assist in preparation, review, submission of Company's regulatory marketing authorization applications.
- Promote the company’s quality management system;
- Contribute to the development and implementation of regulatory strategies, including assessing regulatory impact on product development.
- Collaborate with cross functional teams such as R&D, Product and Clinical Teams in support of regulatory submissions.
- Support the preparation and maintenance of Company's technical documentation and regulatory files in compliance with applicable standards (ISO 13485, 21 CFR 820. IVDR)
- Provide ongoing support to the company’s quality management activities;
- Support Company's post market surveillance activities.
- Relevant Bachelor degree (Law, Industrial Engineering, Biotechnology Engineering, Life Science/ Exact Science)
- Experience with medical device’s Regulatory Affairs (RA) – Advantage.
- Understanding of Quality Assurance processes and methodologies (ISO 13485:2016, ISO 9001:2015 or similar) – Advantage
- Team player
- Self-learner, highly motivated and independent individual
- Excellent communication skills (both written and verbal)
- Strong attention to details
- English Proficiency